Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06214728 |
| Other study ID # |
UGUNDOGDU1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 16, 2022 |
| Est. completion date |
May 12, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Bezmialem Vakif University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aim:
The aim of this randomised, parallel-arm, blinded, controlled clinical trial was to compare
the clinical and radiographic efficacy of MINST with and without 0.8% HA gel application in
the treatment of intraosseous defects.
Research Hypothesis:
The null hypothesis that there is no statistically significant difference in clinical and
radiographic measurements between the use of HA gel in addition to MINST for the treatment of
intraosseous defects and MINST treatment alone was tested.
Description:
This study was designed as a randomised controlled clinical trial and conducted between March
2022 and May 2023 at the Department of Periodontology, Bezmialem Vakıf University. Ethical
approval was obtained from Clinical Research Ethics Committee of Bezmialem Vakıf University
with approval number E.54753 on March 15, 2022.
The patients included in our study were selected from a total of 140 patients with complaints
of gingival problems who applied to the Department of Periodontology at Bezmialem Vakıf
University Faculty of Dentistry, specifically those having intraosseous defects in the
premolar/molar teeth. Forty-two individuals were included in the study, and it was completed
with a total of 36 participants, consisting of 25 females and 11 males.
Initial clinical periodontal measurements and periapical radiographs were taken from the
defect area with parallel technique in the first session. Occlusal stents with fixed guide
points were prepared to place the periodontal probe with the correct angle and inclination.
During the initial session, complete oral supragingival calculus cleaning and oral hygiene
motivation were performed. After that, patients were randomly assigned to the test (MINST +
HA, n = 17) or control (MINST, n = 19) groups. Neither the patients nor the expert
responsible for the clinical measurements (UGE) was aware of which treatment each individual
had received.
The MINST concepts described by Nibali et al. were followed in the treatment protocol. During
the procedure, a subpapillary approach was taken to reduce trauma to the soft tissues,
particularly the papillae, using a 2.5x420 mm magnification loop . The instruments were
gently placed within the periodontal pocket while the patient was under local anaesthesia ,
in order to keep the soft tissues stable. Using mini five curettes and ultrasonic devices
with precise tips ,the root surfaces were cleaned reaching to the base of the pocket,
avoiding excessive root surface smoothing and gingival curettage. The subgingival area was
not irrigated to prevent deterioration of clot stabilisation during the wound healing process
[1]. MINST was performed in all areas of the oral cavity with periodontal pockets >3 mm. The
control group was treated with MINST alone without using any irrigation solution. Beside, in
the test group, following MINST protocol same as in the control, HA gel was applied to the
periodontal pockets where the intraosseous defect was located using a sterile injector with a
plastic needle. The gel was applied until it overflowed from the gingival sulcus. Patients
were instructed not to eat, drink or brush their teeth for at least one hour. Subgingival
application of HA was repeated 4 weeks after the first session. The control group received
placebo HA gel probe without rinsing.
Clinical examination Initial clinical measurements were taken by a single investigator (UGE)
using the UNC15 probe at six sites on all teeth to determine the stage and grade of
periodontitis in study population.
Clinical periodontal measurements of the defect site were recorded at baseline and repeated
at 3 and 6 months following treatment. Probing depth (PD), clinical attachment level (CAL)
and gingival recession (GR) measurements were made from two points including buccal and
lingual area through a patient-specific acrylic stent in the defect area and recorded as
average and deepest/worst. Bleeding on probing (BoP) and presence of plaque (P) were
evaluated as present/absent in the buccal and lingual part of the defect area and recorded as
%.
The gingival phenotype was evaluated by observing the probe's silhouette visibility using
biotype probe located in the buccal point of the intraosseous defect area.
Pre-study investigator calibration was performed by repeating the PD and CAL measurements of
10 periodontitis patients who were not included in the study at 24 hours intervals. The
intraclass correlation showed that the researcher's repeatability was at an acceptable level
(PD; k-score: 0,817-0,952; CAL:0,836-0,926).
Radiographic examination For the diagnosis of intraosseous defects radiographs were taken at
baseline and 6-month follow-up using a custom-made radiographic stent and the parallel cone
technique. Radiographs were digitized and analysed by a single calibrated investigator using
a computer software (Planmeca Romexis Viewer software). The radiographs were numbered prior
to analysis to blind the analyst to the groups of radiographs. For investigator calibration,
measurements of intraosseous defect depth (infra) and defect angle of periapical radiographs
from 10 nonstudy patients were repeated at 24-hour intervals. Intra-class correlation
coefficients ranging from 0.86 to 0.92 for the defect depth and angle measurements and it was
determined that the reproducibility of the researcher was at an acceptable level.
Radiographic measurements were made by using the reference points on tooth surface. Total
defect depth (TDD): The distance from the cemento- enamel junction to the base of the defect
(CEJ-DD) was measured. Intraosseous defect depth (INFRA): It is the distance from the
projection of the alveolar crest point on the tooth to the bottom of the defect (DD).
Distance from the CEJ to the alveolar crest (CEJ-BC): It is the distance from the projection
of the alveolar crest point on the tooth and the cemento enamel junction (CEJ). Intra-osseous
defect angle: The radiographic defect angle was measured between the CEJ-BD line of the
involved tooth and the bone defect surface.
